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临床试验/NCT02293473
NCT02293473已完成不适用

The Impact of Multimodal Monitoring During Major Surgery on the Morbidity, Mortality and Duration of Hospital Stay in UMC Ljubljana

University Medical Centre Ljubljana2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
2
主要终点
Reduced hospital stay

研究概览

简要总结

This study is designed to test if measuring the depth of anaesthesia, brain tissue oxygenation and haemodynamic parameters and specially designed interventions according to the measurements can improve the outcome of high risk surgical patients undergoing major abdominal surgery.

详细描述

All patients will be visited by a member of our team a day prior to surgery to seek an informed consent and to answer any questions. A set of laboratory results (see below) will be sought.

A test (Mini Mental test) will be performed to evaluate patients' cognitive functions. Our patients are fasted.

I. PROTOCOL GROUP

Pre-induction After the insertion of an intravenous catheter all patients will receive premedication (midazolam (Dormicum®) 1-2mg iv) and an arterial catheter will be inserted under local anaesthesia. Thoracic epidural catheter will be inserted in left lateral decubitus position (intervertebral space Th 7-8, or Th 9-10 for low intestinal surgery) and test with 3 ml of 2% lidocaine (Xylocaine®) will be performed.

LiDCO Rapid® (haemodynamics), unilateral INVOS® (brain tissue oxygenation) and unilateral BIS® (depth of anaesthesia) monitors will be applied. Should there be pre-existing carotid stenosis, INVOS® sensor will be applied on the ipsilateral side. In case of pre-existing cerebral pathology, the INVOS® sensor will be applied to the contralateral side. Baseline values of nominal stroke index (SI), cardiac index (CI), BIS value, mean arterial pressure (MAP) and regional tissue oxygen saturation (rSO2) will be recorded. Basal rSO2 will be recorded prior to preoxygenation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • stomach surgery
  • Pancreas surgery
  • Large intestinal resections
  • High risk surgical patients (ASA /American Society of Anesthesiologists/ 2-3 )

排除标准

  • Pregnant women
  • Laparoscopic surgery
  • Palliative procedures

研究组 & 干预措施

Protocol Group

Experimental

Using multimodal monitoring to optimise the patients' haemodynamic status, namely, the use of LiDCO Rapid, BIS-Bispectral Index Monitor and INVOS-Cerebral Oxygenation Monitor monitors to assess and "fine tune" the patient, as described in the study protocol in detail.

干预措施: LiDCO Rapid (Device)

Protocol Group

Experimental

Using multimodal monitoring to optimise the patients' haemodynamic status, namely, the use of LiDCO Rapid, BIS-Bispectral Index Monitor and INVOS-Cerebral Oxygenation Monitor monitors to assess and "fine tune" the patient, as described in the study protocol in detail.

干预措施: BIS-Bispectral Index Monitor (Device)

Protocol Group

Experimental

Using multimodal monitoring to optimise the patients' haemodynamic status, namely, the use of LiDCO Rapid, BIS-Bispectral Index Monitor and INVOS-Cerebral Oxygenation Monitor monitors to assess and "fine tune" the patient, as described in the study protocol in detail.

干预措施: INVOS-Cerebral Oxygenation Monitor (Device)

Control Group

Active Comparator

Using current standard of care

干预措施: Standard of care (Other)

结局指标

主要结局

Reduced hospital stay

时间窗: after release from hospital, an expected average of 10 days after surgery

We are trying to prove that the protocol group will have a reduced hospital stay of 2 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. Vesna Novak Jankovic, MD PhD

prof. Vesna Novak Jankovic, MD, PhD

University Medical Centre Ljubljana

研究点 (2)

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